[Ip-health] Devex: Member states clash as WHO mulls how to make medicine accessible to all

Thiru Balasubramaniam thiru at keionline.org
Tue Jan 30 04:49:54 PST 2018


Inside Development
World Health Organization

Member states clash as WHO mulls how to make medicine accessible to all

By Jenny Lei Ravelo // 30 January 2018

World Health Organization member states agree on the importance of access
to medicines to achieve universal health coverage, but at the recently
concluded 142nd session of WHO’s executive board, it was clear they have
different and strong opinions on how to make that happen.

The issue of timely access to quality, affordable health products —
medicines, vaccines, diagnostic tools — has become a huge topic in global
health in recent years, not only among developing countries but even among
high income ones. The high cost of products such as cancer medicines, for
example, have prompted calls from different quarters for transparency of
research and development costs — particularly by pharmaceutical companies.
One of the most expensive cancer drugs out in the market today to treat
leukemia among children and young adults costs nearly $500,000 per patient.

But the issue has been of particular significance to developing nations,
whose populations are not only struggling to keep up with costs of
expensive drugs for noncommunicable diseases, but also for lifesaving ones
such as pneumococcal vaccine, drugs for tuberculosis, and hepatitis C.

13 things to know about WHO's Geneva deliberations

While the world’s elite gathered atop the snowy mountains of Davos, health
ministers and other stakeholders hammered out the details of a number of
global health priorities in Geneva. Here’s what to know about the World
Health Organization's weeklong 142nd executive board meeting.

As much as 90 percent of populations in developing countries pay out of
pocket for medicines, according to WHO’s latest report presented to member
states. This puts huge numbers of people at risk of financial hardship,
posing significant challenge to attaining universal health coverage, an
overarching goal in the Sustainable Development Goals and the central theme
in Director-General Tedros Adhanom Ghebreyesus’ vision and mission for
WHO’s work in the next five years.

The topic has been discussed for years at the executive board and at the
World Health Assembly. To illustrate, WHO’s latest report is based on a
review of 50 World Health Assembly resolutions directly or indirectly
related to the issue of medicine access, 45 regional technical
consultations and 67 technical documents, said Dr. Mariângela Batista
Galvão Simão, WHO’s new assistant director-general for drug access,
vaccines, and pharmaceuticals. The report covers different priorities of
action for member states, depending on the level of complexity and the
amount of resources needed to implement them. It also looks into areas
where WHO needs to step up knowledge and action on its technical support
function, from inducing savings through innovative procurement approaches
to helping countries navigate the flexibilities provided in the
trade-related aspects of intellectual property rights, or TRIPS, an
international, legally binding agreement between countries and the World
Trade Organization.

“This is the third year in a row that this item is both in the EB and WHA
agendas, and this reflects how important it is and also the complexity of
access to safe, quality-assured, affordable medicines, vaccines, and
pharmaceutical products, including diagnostics and medical devices and
other health technologies” said Simão, who underlined the need to
streamline and prioritize action on the issue.

As if conditioning member states, the assistant director-general said: “The
decisions we make on this board have consequences in the real world, and
they affect how this outcome of people having access to different
technologies can actually take place.”

A step forward for medicine access

A number of member states echoed the assistant director-general’s message
of how important, and difficult, the issue of access to medical products
are in their respective countries. Speaking on behalf of Eastern
Mediterranean countries, Jordan’s representative said access to quality
assured and affordable medicine is a problem faced by many of the countries
in their region, including those with middle-income status, and that they
require WHO’s support on supply chain management and procurement “both in
normal and emergency situations.”

Netherlands, a high-income country, shared the same sentiment.

“We urgently need comprehensive guidance and assistance from WHO, taking
into account all aspects, also the difficult ones, such as fair pricing,
quality of drugs, appropriate use and of course [intellectual property],”
the representative said, adding that they, too, are considering the
application of compulsory licensing — allowing the manufacture of products
under patent without seeking consent of patent holders — but like many
countries face difficulties, political and legal.

The Brazilian representative, meanwhile, underscored just how hugely
relevant access and affordability is across all the issues being discussed
by the executive board.

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“It is useless, for example, for a country to offer broad health coverage
if individuals who seek medical facilities do not receive medicines or
cannot purchase them. It is pointless to deploy a costly response team or
the health reserve forces so central to [the director-general’s] vision of
a transformed WHO if they do not have the means to quell an emergency, or
to immunize and treat displaced populations,” the Brazilian representative

Both Brazil and the Netherlands ended their speeches asking the
director-general to take a stand and put public health needs at the center
of the discussions on access to “keep people from dying before their time.”

Some member states, such as Japan and the United States, raised questions
on the report and the roadmap outlining WHO’s work on access to medicines
and vaccines for the period 2019-2023, but in the end agreed to adopt the
proposed decision put forward by Brazil and other countries.

But it was a different ball game altogether when member states started
talking about the global strategy and plan of action on public health,
innovation and intellectual property, or GSPoA, which has been adopted by
the World Health Assembly a decade ago but have not seen full
implementation to date.

A long road to consensus

A number of member states were proposing a draft resolution that allows WHO
and its member states to take forward the recommendations of the expert
panel WHO convened to do a program review of the GSPoA. The new set of
recommendations mostly came from the GSPoA, but the difference is that it
contains a more focused set of actions for WHO and member states. The panel
reduced the recommendations from 108 to 33, but that included a few
additions that sparked hours of debate and negotiations between countries.
The additions were aimed at promoting transparency and understanding of
research and development costs, and asking member states to dedicate at
least 0.01 percent of their gross domestic product to “basic and applied
research relevant to the health needs of developing countries.”

The representative from Japan noted that R&D promotion is very important to
progress on UHC. But he argued that it can only be done by providing
incentives to companies in the development of news drugs, and that means
providing “adequate protection” of intellectual property. He also raised
concerns on the added recommendations, and asked the board more time to
understand their full implications.

The United States representative meanwhile was more direct in saying his
delegation cannot support the draft decision point proposed, and requested
the creation of a drafting group to make revisions. He argued that some of
the recommendations weren’t based on consensus among member states. A
recommendation on transparency that seeks to calculate and get companies to
disclose their R&D costs “are impractical and unlikely to be effective,”
the representative said. Instead, he argued, such an approach could only
result in companies abandoning research that could be most beneficial to
communities and “humanity as a whole.”

“In addition, we do not support calls for WHO advocacy and areas outside
its mandated expertise, including intellectual property rights for which
potential long-term consequences to global innovation would be
devastating,” the representative added. “The United States maintains it’s
inappropriate for WHO to intervene on matters in the domain of the World
Trade Organization, particularly with respect to interpreting member
states’ legally binding TRIPS obligations.”

WHO’s future action, the U.S. representative said, should focus on areas
where there are consensus, and member states should focus on policies that
“genuinely promote access to medicines while continuing to allow the global
innovation system to flourish.”

Since the United States is not a member of the board, Japan agreed to file
their request for a revision of the proposed draft decision point before
the executive board.

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But the U.S. response triggered a series of reactions among member states.
It was apparent that similar arguments have been made in the past, and some
member states are wary that the discussions would again lead nowhere.

“GSPoA is not against protection of intellectual property. On the
contrary,” said the Brazilian representative. “We have gone through the
motions for the last 10 years, like Congo put very well, we have discussed,
we have negotiated, we have agreed within this EB, we have sent our
agreement to the WHA, we have agreed at the WHA, then what we had agreed is
not implementable. Then we created a working group. Not implementable. Then
we hired a consultant. Not implementable. Then we put together a group of
experts. Not implementable. Now, not implementable, 10 years later.”

She went on to say that protection is not at risk, and that the
recommendations in the report are not “threatening anyone, any industry.”
She made it clear that the board is not meant to reopen the TRIPS
agreement, but just to ensure all of its aspects are implemented, not just
the intellectual property protection it provides, but also its
flexibilities, from which member states struggling in meeting their
populations’ treatment needs can benefit from.

“This dilatory tactics are not acceptable. They are not adequate. They are
not in line with the mission of WHO,” the representative said, stressing
that Brazil won’t accept any proposals that would delay the
recommendations’ implementations. If there are a few recommendations that
member states such as the U.S. and Japan are wary of, the representative
suggested creating a separate process for those alone, but approve the rest
that raised no issues.

Thailand, Netherlands, Libya, Algeria, and others moved in support of
Brazil’s proposal, while countries such as France and Sweden sided with the
proposal by Canada to create a drafting group that would revisit the
decision point as a means to agree on a compromise, though with a caveat
that only “minor modifications” will be made in the current proposal. After
a few back and forths, Brazil agreed to Canada’s proposal, but stressed
making only “minor adjustments” to the decision point they made.

“We are not committing ourselves to a delay in approval of this decision,”
the Brazilian representative stressed, and adding that the group to work on
the draft be composed of only executive board members.

It wasn’t clear what board members had decided on by the end of the
session, but Devex learned later that an informal group met over lunch time
outside the formal executive board sessions to renegotiate the text, and it
included anyone interested in the decision, board member or not. The
deliberation extended beyond lunch, leaving the Republic of the Congo’s
representative, who earlier expressed being witness to discussions on the
issue at WHA for eight years, wary of the direction of the negotiations.

“I’m not by nature a pessimist, but I think the basis of the problem here
is the consensus of the document before the draft decision. There are
points where there are divergences. If that’s the case, we can hold X
meetings, [but] we’ll never reach an agreement. And I’m afraid this will
start to drift in the wrong direction.”

The representative from Malta however countered, saying the board must not
give up, noting there’s a “lot of goodwill during the negotiations.”

By late evening though, it was clear the drafting group had not reached a
consensus yet. But the following morning, after the board discussed a few
agenda items, Colombia, who co-chaired the drafting group with Malta,
announced they’ve reached consensus.

Mixed reactions

Formally, at the session, members states appeared accepting of the agreed
draft text. But a member of delegation involved in the process told Devex
afterward that the compromised text was reached so as not to risk losing
the whole report altogether. Some of the developed countries, said the
source, who requested to remain anonymous as the negotiations were meant to
be private, were not showing signs of flexibility, and the longer the
negotiations went, the more issues arose. Some of the developed countries
involved, who initially were just focusing on two recommendations, came up
with several other issues, the source said.

“It was very risky, and so we decided to move forward,” the source said.
“So to save it, we had to separate the recommendations.”

The agreed text reads:

View the full text of the global strategy and plan of action on public
health, innovation and intellectual property document here. Source: WHO

Asked what the agreed text means in terms of implementation, the source
said the text allows member states to implement every recommendation,
except for the following, which the agreed decision points specifies
requires further discussion:

1. Member States to support the WHO Secretariat in promoting transparency
in, and understanding of, the costs of research and development.
(Indicator: Reports on the the costs of research and development for health
products prepared in 2019 and 2021.)

2. Member States to identify essential medicines that are at risk of being
in short supply and mechanisms to avoid shortages, and disseminate related
information accordingly. (Indicator: Lists of medicines at risk of being in
short supply and information on mechanisms for preventing shortages made
available and disseminated by 2020.)

3. Member States to commit to dedicating at least 0.01 percent of their
gross domestic product to basic and applied research relevant to the health
needs of developing countries. (Indicator: Percentage of gross domestic
product dedicated to basic and applied research as reported by G-Finder by

“But the thing is, the report itself recognizes that we’re different
recipients of the recommendations. For those related to member states, we
could not get stronger language to call for the implementation without the
caveat of national contexts,” the source said. “But an important aspect is
that the WHO Secretariat will be able to implement the decision.”

As with any negotiations, those who were advocating for a full adoption of
the recommendations were not entirely happy. For example, the language
wasn’t strong enough to persuade member states to implement the
recommendations outside of their “national contexts.” But they had a few
wins, including getting the WHO Secretariat to implement the decision. In
addition, a roadmap for WHO’s work on access to medicines for 2019-2023 was
agreed in a related decision point.

This was seconded by an NGO member who was in Geneva following the
discussions closely.

“The good thing is at least we can now hope for some progress at WHO level
in the priority recommendations, which is about time after 10 years delay,”
an expert on the topic who was following the discussions told Devex,
requesting not to be named to protect their affiliations.

James Love, director of NGO Knowledge Ecology International, said they were
surprised with the U.S. opposition to measures that would make R&D costs
publicly available.

“When negotiating drug prices, or designing and evaluating incentives
mechanisms and new business models, having good and granular data on actual
R&D costs is important. Promoting ignorance to protect excessive prices and
bad business models is inexcusable,” he said in a statement.

But they, too, were encouraged by parts of the decision that gives WHO
broad mandate to act. His colleague, Thiru Balasubramaniam, KEI’s
representative in Geneva, said: “We are heartened that the decision
encourages countries to implement schemes which ‘partially or wholly delink
product prices from R&D costs.’”

What happens here on out will depend on political will.

The representative from Thailand, during the session, called on the
director-general and member states to “walk the talk.” Since 2007, the
representative said WHO has had 50 resolutions and plans on the topic.

“It’s proof that resolutions and plans, without effective actions, waste
our time,” the representative said.

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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